|By PR Newswire||
|January 16, 2014 07:02 AM EST||
WEINHEIM, Germany, January 16, 2014 /PRNewswire/ --
International biotechnology firm Cytonet announced today that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) seeking approval for its liver cell therapy for the treatment of Urea Cycle Disorders (UCD) in children.
UCD is a life-threatening liver metabolism disorder which can affect newborns and infants, causing toxic levels of ammonia to accumulate in the body. This can lead to massive damage of the brain and nervous system. Cytonet's liver cell therapy has the potential to stabilize ammonia levels through infusion of healthy liver cells, potentially increasing the length of time children can safely wait until they can undergo a liver transplant.
"Every life we can save through Liver Cell Therapy is validation of our company's mission. This is a very significant milestone for us," said Dr. Wolfgang Rüdinger, Cytonet's CEO and CSO. Michael J. Deissner, CEO and CFO added: "Currently children with UCD have few effective treatment options. We are committed to doing what it takes to make this therapy available to patients around the world."
Cytonet is conducting a clinical trial in the U.S. and Canada, Safety and Efficacy of Liver Cell Application (SELICA III), designed to test the safety and efficacy of liver cell therapy in infants to children up to five years old with UCD. SELICA III is currently enrolling patients at 11 sites in the United States and Canada.
ABOUT UCD AND LIVER CELL THERAPY
For parents of babies born with UCD, the joy of giving birth to a perfect baby can quickly turn to devastation as the baby's health rapidly declines, going from symptoms such as being tired and irritable, to not eating, to experiencing seizures and coma.
Children left untreated for UCD rarely experience normal physical and mental development. The only cure currently available is liver transplantation, which can be an extremely difficult procedure for the very young. Additionally, there is a shortage of suitable organs available for transplantation.
Liver cell therapy involves collecting healthy cells from donated livers not suitable for transplantation which are then gently isolated and undergo complex processing. These cells are infused into the portal vein over six days.
Cytonet is an international biotechnology company which is located in Weinheim and Heidelberg in Germany and in Durham, NC in the U.S. The company develops and produces cellular products for therapeutic purposes. Cytonet's goal is to provide alternatives to existing therapies for many diseases with a particular emphasis on liver diseases. Cytonet is a pioneer and leader in the field of regenerative medicine. For the past several years, Cytonet has worked with internationally-leading metabolism and neonatal centers to study its liver cell therapy which uses healthy and metabolically functional human liver cells collected from donated livers not suitable for transplant for infusion to treat urea cycle disorders in children. For more information, please visit Cytonet's website at http://www.cytonetllc.com/